The Senior Safety Associate is responsible for the evaluation and management of all incoming reports of adverse events of special interest (AESIs). The employee is responsible for the timely evaluation, review and follow-up related to AESIs in accordance with the regulations and Biogen procedures and conventions. Other key responsibilities include leading adjudication meetings and presenting clinical data on AESIs as well as representing GSRS on key company initiatives to advance the understanding of the safety profile of our products. The employee is also responsible for the training and quality oversight of external partners conducting case processing and follow-up activities on all AESIs and for overseeing certain regulatory commitments related to AESIs

Principle responsibilities

·       Triage of all incoming initial and follow-up AESI reports

·       Evaluation of the existing clinical data points and generation of relevant follow-up queries for all reports of AESI using clinical knowledge, Pharmacovigilance experience, and communication skills within predetermined timelines

·       Collaboration with affiliate/distributor/and associated external AE collection partners for follow-up queries in ROW locations.

·       Direct administration of queries with healthcare providers in the US.

·       Collaboration with US Biogen field staff (MSLs, ABMs) to gather relevant clinical data

·       Presentation of the AESI clinical data to the adjudication committee

·       Documentation and dissemination of key decisions to stakeholders

·       Creation of AESI data collection tools to facilitate the capture of the relevant clinical data necessary for case disposition

·       Support Biogen research initiatives to collect key clinical data points in order to further minimize risk and maximize benefit of Biogen products

·       Achieve and maintain compliance with oversight activities for internal and external partners including performing Quality Review in the Global Safety Database (GSD) and oversight of Follow-up activities conducted by partners on behalf of Biogen GSRS.

·       Support the development and delivery of training material to Case Processing Vendors, the affiliates and distributors, Patient Services and Biogen Field Staff

·       Performs Late Case Investigations and provides Subject Matter Expertise (SME) on AESI ICSR Management

·       Generation and Quality Check of routine periodic regulatory reports.

·       Solid understanding of worldwide Post-Marketing and Clinical Trial Adverse Event Regulations including GCP, CIOMS, EMA GVP

·       Strong ability to understand, evaluate, and succinctly summarize technical, scientific and medical information

·       Ability to work effectively in a collaborative team environment and communicate effectively in a matrix environment

·       Excellent communication skills

·       Excellent organizational skills with an ability to embrace change and multi-task in an extremely fast-paced environment Ability to handle multiple priorities

·       Critical thinker, with an ability to propose solutions

·       Ability to exercise sound judgment in assessing workflow

·       Ability to interpret regulations and apply the interpretation to departmental SOPs and guidelines

·       Good computer skills and ability to learn new systems as they are implemented

·       Minimum of bachelor’s level degree in nursing, pharmacy, or other health related profession

·       3+ years in a clinical setting (preferred but not required)

·       1+ years in Drug Safety department